Apparatus for point of service manufacture of custom cranial remodeling devices

1. Apparatus to provide point of service manufacture of a custom cranial remodeling device for correction of cranial deformity of a subject's head, said apparatus comprising: image capture apparatus disposed at a physical location to capture a three-dimensional image of said subject's head and to generate a three-dimensional digital data file of a head; a three-dimensional digital data file representative of said subject's head generated by said image capture apparatus; an additive manufacture device located at said physical location; a processor, a non-transitory computer readable medium comprising computer executable instructions stored thereon executed by said processor to operate on said three-dimensional digital data file to produce a device file comprising a shape for said custom cranial remodeling device to correct said cranial deformity and computer executable instructions stored thereon executed by said processor to automatically calculate contour lines for said custom cranial remodeling device, said device file comprising said contour lines; a subject device file for said subject's head, said subject device file comprising a shape for said custom cranial remodeling device comprising said contour lines; said subject device file generated by said processor executing said computer executable instructions to operate on said three-dimensional digital data file, said subject device file comprising said shape for said custom cranial remodeling device to correct said cranial deformity for said subject, said subject device file provided to said additive manufacture device; and said additive manufacture device comprising apparatus to receive and utilize said subject device file to manufacture said custom cranial remodeling device at said physical location, said custom cranial remodeling device comprising said contour lines.

2. The apparatus of claim 1 , wherein; said processor is located at one of said physical location or at a location physically removed from said physical location.

3. The apparatus of claim 2 , comprising: said non-transitory computer readable medium with computer executable instructions stored thereon executed by said processor further comprises instructions to provide said device data file with data for one or more removable manufacturing supports; said processor executes said computer executable instructions to provide said subject device file with data for one or more removable manufacturing supports for said custom cranial remodeling device to facilitate additive manufacture of said custom cranial remodeling.

4. The apparatus of claim 3 , comprising: said non-transitory computer readable medium with computer executable instructions stored thereon executed by said processor further comprises instructions to determine a plurality of different layers for incorporation into said custom cranial remodeling device; said processor executes said computer executable instructions to determine a plurality different layers for incorporation into said custom cranial remodeling device and provides data for said different layers in said subject device file; and said additive manufacture is responsive to said subject device file to device manufactures said custom cranial remodeling device with said plurality of different layers.

5. The apparatus of claim 4 , comprising: said non-transitory computer readable medium with computer executable instructions stored thereon executed by said processor further comprises instructions to select said plurality of different layers to comprise one or both of different strength and material properties; and said processor executes said computer executable instructions to automatically select said plurality of different layers to comprise one or both of different strength and material properties, said processor including said selected plurality of different layers in said subject device file.

6. The apparatus of claim 5 , comprising: said non-transitory computer readable medium with computer executable instructions stored thereon executed by said processor further comprises instructions to select said plurality of different layers to apply different forces over different areas of said head; and said processor executes said computer executable instructions to automatically select for inclusion in said subject device file said plurality of different layers to apply different forces over different areas of said head.

7. The apparatus of claim 6 , comprising: said non-transitory computer readable medium with computer executable instructions stored thereon executed by said processor further comprises instructions to select said plurality of different layers such that none of said different layers comprises a foam layer; and said processor executes said computer executable instructions to select said plurality of different layers in said subject device file such that none of said different layers comprises a foam layer.

8. The apparatus of claim 7 , comprising: said non-transitory computer readable medium with computer executable instructions stored thereon executed by said processor further comprises instructions to generate alignment marks; and said processor executes said computer executable instructions to generate alignment marks in said subject device file; and said additive manufacture device executes said subject device file to print alignment marks on said custom cranial remodeling device to aide fitting said custom cranial remodeling device.

9. The apparatus of claim 6 , comprising: said non-transitory computer readable medium with computer executable instructions stored thereon executed by said processor further comprises instructions to select said plurality of different layers such that one of said different layers comprises a foam layer; and said processor executes said computer executable instructions to select said plurality of different layers in said subject device file such that one of said different layers comprises a foam layer.

10. The apparatus of claim 9 , comprising: said non-transitory computer readable medium with computer executable instructions stored thereon executed by said processor further comprises instructions to generate guidelines data; and said processor executes said computer executable instructions to generate guidelines data in said subject device file; and said additive manufacture device utilizes said subject device file to print guidelines on said custom remodeling device.

11. The apparatus of claim 4 , comprising: said non-transitory computer readable medium with computer executable instructions stored thereon executed by said processor further comprises instructions to select said plurality of different layers to apply different forces over different areas of said head; and said processor executes said computer executable instructions to automatically select said plurality of different layers for inclusion in said subject device file to apply different forces over different areas of said head.

12. The apparatus of claim 11 , comprising: said non-transitory computer readable medium with computer executable instructions stored thereon executed by said processor further comprises instructions to select said plurality of different layers such that none of said different layers comprises a foam layer; and said processor executes said computer executable instructions to select said plurality of different layers for inclusion in said subject device file such that none of said different layers comprises a foam layer.

13. The apparatus of claim 12 , comprising: said non-transitory computer readable medium with computer executable instructions stored thereon executed by said processor further comprises instructions to generates alignment mark data; and said processor executes said computer executable instructions to generate alignment mark data in said subject device file for alignment marks to be printed on said custom cranial remodeling device to aide fitting said custom cranial remodeling device; and said additive manufacture device utilizes said subject device file to print said guidelines on said custom cranial remodeling device.

14. The apparatus of claim 11 , comprising: said non-transitory computer readable medium with computer executable instructions stored thereon executed by said processor further comprises instructions to select said plurality of different layers such that one of said different layers comprises a foam layer; and said processor executes said computer executable instructions to select said plurality of different layers for inclusion in said subject device file such that one of said different layers comprises a foam layer.

15. The apparatus of claim 14 , comprising: said additive manufacture device utilizes said subject device file to print clinician guidelines on said custom cranial remodeling device.

16. The apparatus of claim 3 , comprising: said non-transitory computer readable medium with computer executable instructions stored thereon executed by said processor further comprises instructions to generate electronic sensor manufacture data; and said processor executes said computer executable instructions to generate electronic sensor manufacture data in said subject device file; and said additive manufacture device utilizes said electronic sensor data to automatically manufacture one or more corresponding electronic sensors into said custom cranial remodeling device.

17. The apparatus of claim 3 , comprising: said non-transitory computer readable medium with computer executable instructions stored thereon executed by said processor further comprises instructions to generate electronic sensor manufacture data for electronic pressure sensors; and said processor executes said computer executable instructions to generate electronic sensor manufacture data in said subject device file, said electronic sensor is operable to determine pressure level applied to said head when said custom cranial remodeling device is worn on said head; and said additive manufacture device utilizes said electronic sensor data to automatically manufacture one or more corresponding electronic sensors into said custom cranial remodeling device.

18. The apparatus of claim 3 , comprising: said non-transitory computer readable medium with computer executable instructions stored thereon executed by said processor further comprises instructions to generate electronic sensor manufacture data; and said processor executes said computer executable instructions to generate electronic sensor manufacture data in said subject device file for an electronic sensor operable to confirm that said custom cranial remodeling device is being correctly worn on said head; and said additive manufacture device utilizes said electronic sensor data to automatically manufacture one or more corresponding electronic sensors operable to confirm that said custom cranial remodeling device is being correctly worn on said head into said custom cranial remodeling device.

19. The apparatus of claim 3 , comprising: said non-transitory computer readable medium with computer executable instructions stored thereon executed by said processor further comprises instructions to manufacture one or more electronic transducers; said processor executes said computer executable instructions to generate electronic transducer manufacture data in said subject device file; and said additive manufacture device utilizes said subject device file to automatically print one or more electronic transducers into said custom cranial remodeling device.

20. The apparatus of claim 19 , wherein: said one or more electronic transducers are useable to determine one or more of tilt and turn of said head, whether said custom cranial remodeling device is being worn, and the frequency of predetermined head motions.

21. The apparatus of claim 3 , comprising: said non-transitory computer readable medium with computer executable instructions stored thereon executed by said processor further comprises instructions to manufacture one or more components; said processor executes said computer executable instructions to generate component manufacture data in said subject device file; and said additive manufacture device utilizes said subject device file to automatically manufacture components integral with said custom cranial remodeling device.

22. The apparatus of claim 21 , wherein: said components comprise one or more of apparatus for fastening said custom cranial remodeling device in place on said head, electronic transducers, and electronic sensors.

23. The apparatus of claim 4 , comprising: said non-transitory computer readable medium with computer executable instructions stored thereon executed by said processor further comprises instructions to identify regions on the interior of said cranial remodeling device where one layer of said plurality of layers is to contact said head and other regions on the interior of said custom cranial remodeling device where the interior surface of said custom cranial remodeling device is to be spaced apart from said head; said processor executes said computer executable instructions to identify regions on the interior of said cranial remodeling device where one layer of said plurality of layers is to contact said head and other regions on the interior of said custom cranial remodeling device where the interior surface of said custom cranial remodeling device is to be spaced apart from said head; and said processor executes said computer executable instructions to provide said subject device file with data that identifies regions on the interior of said cranial remodeling device where one layer of said plurality of layers is to contact said head and other regions on the interior of said custom cranial remodeling device where the interior surface of said custom cranial remodeling device is to be spaced apart from said head.

24. The apparatus of claim 23 , comprising: said additive manufacture device utilizes said subject device file to manufacture said custom cranial remodeling device with said regions and other regions.